Cleared Traditional

K082063 - PRELUDE SHORT SHEATH INTRODUCER

K082063 is the FDA 510(k) clearance for PRELUDE SHORT SHEATH INTRODUCER by Merit Medical Systems, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K082063 · Merit Medical Systems, Inc. · Cardiovascular device
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Oct 2008
Decision
86d
Days
Class 2
Risk

K082063 is an FDA 510(k) clearance for the PRELUDE SHORT SHEATH INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on October 15, 2008 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Merit Medical Systems, Inc. devices

Submission Details

510(k) Number K082063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2008
Decision Date October 15, 2008
Days to Decision 86 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 125d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DYB Introducer, Catheter

All 383
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K082063.
AGILIS NXT STEERABLE INTRODUCER, MODEL G408324
K081645 · St Jude Medical · Dec 2008
AGILIS NXT STEERABLE INTRODUCER
K083083 · St Jude Medical · Nov 2008
PINNACLE ROII INTRODUCER SHEATH
K082847 · Terumo Medical Corp. · Oct 2008
GLIDESHEATH
K082644 · Terumo Medical Corp. · Sep 2008
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
K082356 · W.L. Gore & Associates, Inc. · Aug 2008
DESTINATION RENAL GUIDING SHEATH
K081045 · Terumo Medical Corp. · May 2008